The US Food and Drug Administration (FDA) announced Wednesday that severe genital infection has been reported in patients who have taken a particular class of diabetes medications.
The alert refers to a class of drugs called SGLT2 inhibitors, first approved in 2013 to lower blood sugar levels in adults with type 2 diabetes.
The US Department of Health has also called for this risk to be included in the labeling of medicines.
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FDA-approved SGLT2 inhibitors include Johnson & Johnson's Invokana, Eli Lilly & Co.'s Jardiance, and Bristol-Myers Squibb, Astra Zeneca Plc, Merck & Co and Pfizer Inc.
Companies have not responded immediately to Reuters request for comment.
Patients are at risk of infection known as Fournier gangrene, an extremely rare, but life-threatening bacterial infection of the tissue under the skin surrounding the genital area, the FDA said in a statement.
The bacteria usually get through a cut in the body and spread quickly. Diabetes is a risk factor for the development of Fournier gangrene.
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The FDA said it identified 12 cases of Fournier gangrene – 7 in men and 5 in women – between March 2013 and May 2018.
One patient died while some required multiple disfiguring surgeries and developed complications, the agency said.
The infection developed within a few months after the patients had received a SGLT2 inhibitor and the drug was stopped in most cases, the FDA said.